Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01089413
First received: March 15, 2010
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab [Avastin] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is >300 patients.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Drug: bevacizumab [Avastin] |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Multicenter, Non-interventional, Post-authorization Study to Observe in Daily Clinical Practice the Treatment Duration of Patients Treated With Avastin (Bevacizumab) in 1st Line mCRC in Belgium |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Observation of treatment duration in daily clinical practice [ Time Frame: Throughout study, approximately 34 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival in a daily clinical practice setting [ Time Frame: Throughout study, approximately 34 months ] [ Designated as safety issue: No ]
- Identification of reasons for stopping treatment [ Time Frame: Throughout study, approximately 34 months ] [ Designated as safety issue: No ]
- Patient and tumor characteristics: Anthropometric characteristics, performance status, medical, family and disease history [ Time Frame: Throughout study, approximately 34 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Cohort |
Drug: bevacizumab [Avastin]
As prescribed by physician
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with 1st line treatment with bevacizumab in Belgium
Criteria
Inclusion Criteria:
- adult patients =/<18 years of age
- metastatic colorectal cancer
- patients for whom the physician has prescribed bevacizumab [Avastin] for the treatment of 1st line metastatic colorectal cancer
- patients, who have given written informed consent
Exclusion Criteria:
- hypersensitivity to recombinant human or humanised antibodies
- pregnancy or breast-feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089413
Contacts
| Contact: Please reference Study ID Number: ML25117 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Belgium | |
| Completed | |
| Aalst, Belgium, 9300 | |
| Completed | |
| Antwerpen, Belgium, 2020 | |
| Active, not recruiting | |
| Assebroek, Belgium, 8310 | |
| Completed | |
| AYE, Belgium, 6900 | |
| Active, not recruiting | |
| Brugge, Belgium, 8000 | |
| Completed | |
| Bruxelles, Belgium, 1180 | |
| Completed | |
| Charleroi, Belgium, 6000 | |
| Completed | |
| Haine-saint-paul, Belgium, 7100 | |
| Completed | |
| Hasselt, Belgium, 3500 | |
| Completed | |
| Ieper, Belgium, 8900 | |
| Completed | |
| Kortrijk, Belgium, 8500 | |
| Active, not recruiting | |
| Liege, Belgium, 4000 | |
| Recruiting | |
| Mons, Belgium, 7000 | |
| Completed | |
| Mons, Belgium, 7000 | |
| Completed | |
| Namur, Belgium, 5000 | |
| Completed | |
| Roeselare, Belgium, 8800 | |
| Completed | |
| Sint-niklaas, Belgium, 9100 | |
| Completed | |
| Tongeren, Belgium, 3700 | |
| Completed | |
| Tournai, Belgium, 7500 | |
| Completed | |
| Vilvoorde, Belgium, 1800 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01089413 History of Changes |
| Other Study ID Numbers: | ML25117 |
| Study First Received: | March 15, 2010 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013